(Withdrawal) AI-Based Low-Dose 3D-DSA Reconstruction

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology

About this trial

If the participants agree to participate in this study, the participants will undergo two scans (classic 3D-DSA and PS-3D-DSA assisted scan) to compare the imaging effects of both. After the procedure, the investigators will record the radiation exposure and collect DSA images.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age ≥18 years.

Requires 3D-DSA-guided interventional diagnosis or treatment (e.g., cerebral angiography, cerebral artery chemoembolization) and meets operational indications.

Can understand the study's purpose, procedures, potential risks, and benefits, and voluntarily signs a written informed consent form.

Disqualifiers

Severe heart or lung disease, such as heart failure or chronic obstructive pulmonary disease (COPD).

History of high-dose radiation exams or treatments.

Known allergies or severe adverse reactions to iodine contrast agents or other relevant medications.

Pregnant or breastfeeding women.

Trial design

Design model

Crossover

Treatments tested in this trial

  • PS-3D-DSA

    Radiation

    undergo a PS-3D-DSA scan

  • classic 3D-DSA

    Radiation

    undergo a classic 3D-DSA scan

Treatment groups

134 Participants
are divided into 2 treatment groups
Group A: PS-3D-DSAExperimental treatment 1 intervention
Group B: classic 3D-DSASham comparator 1 intervention

Trial outcomes

Primary outcomes

1

The radiation dose received by patients during interventional procedures when using two scanning protocols (classic 3D-DSA and PS-3D-DSA)

Using the built-in radiation monitoring function of interventional surgical equipment (DSA system), the radiation dose (AK,air kerma) received by the patient during the procedure is directly measured and recorded. The collected radiation dose data is documented in the patient's medical records and stored in the research database for subsequent analysis and comparative studies.

Time frame
No more than 6 hours

Secondary outcomes

1

The image diagnostic capabilities using two scanning protocols (classic 3D-DSA and PS-3D-DSA)

The secondary outcomes focus on evaluating the performance of interventional radiologists using either PS-3D-DSA or classic 3D-DSA for diagnostic tasks, with accuracy as the primary measure. Specifically, the diagnostic results from multiple radiologists will be compared against the gold standard to determine the level of agreement and diagnostic accuracy. This comparison will involve calculating sensitivity, specificity, and overall accuracy. Furthermore, receiver operating characteristic (ROC) curves will be plotted to assess the diagnostic performance and to visually represent the trade-off between sensitivity and specificity for each method.

Time frame
No more than 1 month

Other outcomes

1

Comparison of image quality using two scanning protocols (classic 3D-DSA and PS-3D-DSA)

Algorithmic performance for image quality and interventional radiologists' scoring of image. Specifically, multiple radiologists will provide subjective ratings of image quality, with the best quality rated as 5 and the worst as 1. Image Quality (5 points): 1. point: The smoothness of the video is very poor, with noticeable stuttering in the animation, making it nearly impossible to provide a smooth viewing experience. 2. points: The smoothness of the video is poor, with a delayed animation, resulting in a less-than-ideal viewing experience. 3. points: The smoothness of the video is average, the animation is relatively smooth, offering a satisfactory viewing experience. 4. points: The smoothness of the video is high, with smooth and natural animation, providing an excellent viewing experience. 5. points: The smoothness of the video is extremely high, with exceptionally smooth animation, providing an outstanding viewing experience.

Time frame
No more than 1 month

Sponsors and contacts

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